The AVP II is a self-expandable nitinol mesh occlusion device (Figs. 3.1d and 3.3c, d). It has three segments, including the central lobe, and two discs on each side of the lobe. Because of its tri-lobar design, AVP II has six layers of mesh, giving the device better occlusive properties. It is available in diameters ranging from 3 mm to 22 mm. The device comes preloaded and has a proximal microscrew to permit the attachment to a delivery cable. It can be implanted through a 4 Fr long sheath for 3–8 mm devices, through a 5 Fr long sheath for 10 and 12 mm devices, through a 6 Fr sheath for 14 and 16 mm devices and through a 7 Fr long sheath for larger devices (Table 3.1).

Sorajja et al. [26] reported a retrospective review of 126 patients undergoing percutaneous PVL closure. The AVP II was the device most used. Technical and procedure success were 91 and 76%, respectively. The 3-year estimate for survival was 64.3% (95% confidence interval, 52.1–76.8%). Among survivors, 72% of patients who had presented with heart failure were free of severe symptoms and need for cardiac surgery. For those with no, mild, or moderate or severe residual regurgitation, 3-year estimate of survival free of death or need for surgery was 63.3%, 58.3%, and 30.3% (p = 0.01), respectively.

Also, Ruiz et al. [8] reported a series of 43 patients (57 percutaneous PVLs) undergoing percutaneous PVL closure. The ADO device was used in 68.9% of the procedures, the AmVSDo (Amplatzer muscular VSD occluder) device in 18.7%, the AVP II device in 8.3%, and the ASO (Amplatzer septal occluder) device in 4.1%. Closure was successful (deployment of an occlusive device across the paravalvular leak without any mechanical interference with the valve prosthesis) in 86% of defects, and clinical success was achieved in 86% of the patients in whom procedure was successful. The survival rates for patients at 6, 12, and 18 months after PVL closures were 91.9%, 89.2%, and 86.5%, respectively.

The AVP III is a nitinol-based device with an elliptical lobe that adapts to the often crescent-shaped defects. The lobe is covered by two discs on each side protruding from the lobe by only 2 mm, in order to reduce the risk of interference with mechanical valve leaflets (Figs. 3.1e and 3.3a, b). Different sizes from 4 × 2 mm to 14 × 5 mm are available, fitting through a 4–7 Fr sheath (Table 3.1). The AVP III device sizing requires careful examination of the PVL anatomy, specifically, the diameter and length of the defect, and its relationship to the surrounding cardiac structures. This device received the EC Mark in 2008 for vascular occlusion. It does not have FDA approval.

Nietlispach et al. [9] first reported feasibility, safety, and efficacy of AVP III for PVL closure. In this study, five patients with severe paravalvular mitral and aortic regurgitation underwent PVL closure. Implantation of the device was successfully accomplished in all. There was no procedural mortality. At a median follow-up of 191 days (interquartile range [IQR] 169–203 days), all patients were alive. Also, patients have shown significant improvement in NYHA functional class, hemoglobin and creatinine levels. Median echocardiographic follow-up at 58 days (IQR 56–70 days) reported residual regurgitation to be reduced from grade 4 to grade 2 (IQR 1.5–2.25).

Cruz-Gonzalez et al. [10] reported a series of 33 patients (34 PVLs, 27 mitral and 7 aortic) undergoing percutaneous PVL closure using also the AVP III. The device was successfully implanted in 94% of patients, and successful closure (defined as regurgitation reduction ≥1 grade) was achieved in 91% of patients. There were no procedure-related deaths, myocardial infarctions, or stroke. At 90 days, survival was 100%, and more than 90% showed significant clinical improvement. Also, Sanchez-Recalde et al. [22] reported a series of 20 patients with PVLs. Closure was attempted for 23 PVLs (17 mitral and 6 aortic). The AVP III device was used in 18 patients (86%). Implantation was successful in 87% of the defects, and the procedure was successful in 83% (with success being defined as a reduction in regurgitation of ≥1 degree). Survival at 1 year was 64.7% and survival free of the composite event of death/surgery was 58.8%. Survivors showed significant improvement in functional class.

The AVP IV is a double-lobed occluder device (Figs. 3.1f and 3.3e, f). It has four layers of occluding mesh. The main advantage of this device is the flexibility and small profile. The AVP IV is available in a range of diameters from 4 to 8 mm (Table 3.1). It can be delivered through a 0.038-inch diagnostic catheter lumen and placed in very serpiginous and long tunnel PVLs, such as those that occur after transcatheter aortic valve replacement (TAVR) [27, 28]. Saia et al. [27] recently reported a series of 24 patients (27 procedures) with significant aortic paravalvular regurgitation (PVR) after TAVR underwent percutaneous PVL closure. The most frequently used device was AVP (II, III and IV) in 80% of the cases. Overall, 88.9% (24 of 27) of the procedures were technically successful, and the results assessed by echocardiography were durable. Also, Cruz-Gonzalez et al. have reported a case of severe aortic PVR after TAVR successfully closed using simultaneously AVP III and IV devices [28].

The AVP IV device can be deployed, recaptured and redeployed to assist secure placement. This device received the EC Mark and FDA approval for vascular occlusion.